Knee ArthroplastyNCT06130813
Increased Perioperative Communication Program in Knee Arthroplasty
A study testing increased perioperative communication program in people with Knee Arthroplasty and Postoperative Complications, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Total knee replacement (TKA) is a surgical procedure to increase the function of the knee joint. However, in the postoperative period, it takes a long time for patients to gain independence and adapt to daily life, and they need information and support. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthroplasty, Postoperative Complications
- What is being tested?
- increased perioperative communication program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elective primary unilateral knee arthroplasty planned,
- Having a smartphone,
- Literate,
- Have no communication problems and
- Agreed to participate in the study were included.
Who cannot join
- Those with revision total knee arthroplasty
- Those with bilateral total knee arthroplasty
- Those with speech and hearing disabilities and cognitive problems such as Alzheimer's and dementia
- Patients who do not agree to participate in the study will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cigdem Canbolat Seyman
Ankara, Altındağ, 06600
About this study
Official title: Effect of Increased Perioperative Communication Program on Short-Term Complications in Elective Primary Knee Arthroplasty Patients: A Randomized Controlled Trial
Total knee replacement (TKA) is a surgical procedure to increase the function of the knee joint. However, in the postoperative period, it takes a long time for patients to gain independence and adapt to daily life, and they need information and support. The aim of this study is to determine the effect of the increased perioperative communication program (IPCP) in patients with TKA on early postoperative complications.
Read the detailed description
Total knee replacement (TKA) is a surgical procedure to increase the function of the knee joint. However, in the postoperative period, it takes a long time for patients to gain independence and adapt to daily life, and they need information and support. The aim of this study is to determine the effect of the increased perioperative communication program (IPCP) in patients with TKA on early postoperative complications. This study was approved by the Clinical Research Ethics Committee of Ankara Bilkent City Hospital (No:E1/3573/2023). The population of this study will consist of patients who applied to Ankara Bilkent City Hospital, Orthopedics and Traumatology Outpatient Clinic due to knee osteoarthritis and who are planned to undergo elective total knee arthroplasty. Patients who are planned for elective primary unilateral knee arthroplasty, have a smartphone, are literate, have no communication problems and agree to participate in the study will be included in the study; Patients with revision total knee arthroplasty, bilateral total knee arthroplasty, speech and hearing disabilities, cognitive problems such as Alzheimer's and dementia, and patients who do not agree to participate in the study will be excluded from the study. The sample of the research is; it was determined as 70 patients by G. Power analysis based on the correlation coefficients in a sample study. 35 of the patients will be assigned to the intervention group (IG) and 35 to the control group (CG). Patients in the CG will receive routine perioperative care, while patients in the IG will be included in the IPCP. All patients will be followed for one month after discharge. IPCP consists of 8 informative contents such as preoperative preparations, surgical procedure, pain management, first mobilization, knee joint movements, exercise, discharge process, wound care, showering, nutrition, daily living activities, driving, sexual life, postoperative routine control, unexpected situations and etc. These informative contents will send to patients on days 7th, 4t and 1th days before the surgery and on days 1th, 2th, 3th, 5th an 7th days after surgery via whatsapp. Additionally, all participants will follow postoperative one month. Data will collect using Personal Information Form and Problems Experienced After Discharge Form. Data will analyze using IBM SPSS version 23.0.
- Conditions
- Knee Arthroplasty, Postoperative Complications
- Being tested
- increased perioperative communication program
- Keywords
- knee arthroplasty, communication program, complication, randomized controlled trial
- Medical subject headings
- Postoperative Complications, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increased perioperative communication programOther
Thanks to this communication program, informative content (8 times) will be shared with patients.
| Study group | Role | What they receive |
|---|---|---|
| Increased perioperative communication program | Experimental | The sample of the research is; it was determined as 70 patients by G. Power analysis based on the correlation coefficients in a sample study. 35 of the patients will be assigned to the intervention group (IG) and 35 to the control group (CG). Patients in the CG will receive routine perioperative care, while patients in the IG will be included in the IPCP. All patients will be followed for one month after discharge. IPCP consists of 8 informative contents such as preoperative preparations, surgical procedure, pain management, first mobilization, knee joint movements, exercise, discharge process, wound care, showering, nutrition, daily living activities, driving, sexual life, postoperative routine control, unexpected situations and etc. These informative contents will send to patients on days 7th, 4t and 1th days before the surgery and on days 1th, 2th, 3th, 5th an 7th days after surgery via whatsapp. Additionally, all participants will follow postoperative one month. Receives: Other: increased perioperative communication program |
| Standart of care | No intervention | Patients in the control group will receive routine perioperative care and will follow postoperative for one month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
The investigators expect the IPCP to reduce early postoperative complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start30 Nov 2023
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Canbolat Seyman, Hacettepe University
- Investigators
- Cigdem Canbolat Seyman, PHD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130813
- Sponsor's protocol ID
- HU-SEYMAN-001
- Status last verified
- Oct 2024
- First submitted
- 9 Nov 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will talk about sharing data with other researchers. But it can be useful.
Publications
Yoon RS, Nellans KW, Geller JA, Kim AD, Jacobs MR, Macaulay W. Patient education before hip or knee arthroplasty lowers length of stay. J Arthroplasty. 2010 Jun;25(4):547-51. doi: 10.1016/j.arth.2009.03.012. Epub 2009 May 8.
PubMed 19427164Day MA, Anthony CA, Bedard NA, Glass NA, Clark CR, Callaghan JJ, Noiseux NO. Increasing Perioperative Communication With Automated Mobile Phone Messaging in Total Joint Arthroplasty. J Arthroplasty. 2018 Jan;33(1):19-24. doi: 10.1016/j.arth.2017.08.046. Epub 2017 Sep 19.
PubMed 29017803Karimi AH, Shah AK, Hecht CJ 2nd, Burkhart RJ, Acuna AJ, Kamath AF. Readability of Online Patient Education Materials for Total Joint Arthroplasty: A Systematic Review. J Arthroplasty. 2023 Jul;38(7):1392-1399. doi: 10.1016/j.arth.2023.01.032. Epub 2023 Jan 27.
PubMed 36716898Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.
PubMed 7728691Clarke HD, Timm VL, Goldberg BR, Hattrup SJ. Preoperative patient education reduces in-hospital falls after total knee arthroplasty. Clin Orthop Relat Res. 2012 Jan;470(1):244-9. doi: 10.1007/s11999-011-1951-6.
PubMed 21691907
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Perioperative Communication Program on Short-Term Complications in Elective Primary Knee Arthroplasty Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06130813
- Acronym / sponsor ID
- HU-SEYMAN-001
- Conditions
- Knee Arthroplasty, Postoperative Complications
- Keywords
- knee arthroplasty, communication program, complication, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total knee replacement (TKA) is a surgical procedure to increase the function of the knee joint. However, in the postoperative period, it takes a long time for patients to gain independence and adapt to daily life, and they need information and support. The aim of this study is to determine the effect of the increased perioperative communication program (IPCP) in patients with TKA on early postoperative complications.
Detailed description
Total knee replacement (TKA) is a surgical procedure to increase the function of the knee joint. However, in the postoperative period, it takes a long time for patients to gain independence and adapt to daily life, and they need information and support. The aim of this study is to determine the effect of the increased perioperative communication program (IPCP) in patients with TKA on early postoperative complications. This study was approved by the Clinical Research Ethics Committee of Ankara Bilkent City Hospital (No:E1/3573/2023). The population of this study will consist of patients who applied to Ankara Bilkent City Hospital, Orthopedics and Traumatology Outpatient Clinic due to knee osteoarthritis and who are planned to undergo elective total knee arthroplasty. Patients who are planned for elective primary unilateral knee arthroplasty, have a smartphone, are literate, have no communication problems and agree to participate in the study will be included in the study; Patients with revision total knee arthroplasty, bilateral total knee arthroplasty, speech and hearing disabilities, cognitive problems such as Alzheimer's and dementia, and patients who do not agree to participate in the study will be excluded from the study. The sample of the research is; it was determined as 70 patients by G. Power analysis based on the correlation coefficients in a sample study. 35 of the patients will be assigned to the intervention group (IG) and 35 to the control group (CG). Patients in the CG will receive routine perioperative care, while patients in the IG will be included in the IPCP. All patients will be followed for one month after discharge. IPCP consists of 8 informative contents such as preoperative preparations, surgical procedure, pain management, first mobilization, knee joint movements, exercise, discharge process, wound care, showering, nutrition, daily living activities, driving, sexual life, postoperative routine control, unexpected situations and etc. These informative contents will send to patients on days 7th, 4t and 1th days before the surgery and on days 1th, 2th, 3th, 5th an 7th days after surgery via whatsapp. Additionally, all participants will follow postoperative one month. Data will collect using Personal Information Form and Problems Experienced After Discharge Form. Data will analyze using IBM SPSS version 23.0.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Increased perioperative communication program | Experimental | Other: increased perioperative communication programThe sample of the research is; it was determined as 70 patients by G. Power analysis based on the correlation coefficients in a sample study. 35 of the patients will be assigned to the intervention group (IG) and 35 to the control group (CG). Patients in the CG will receive routine perioperative care, while patients in the IG will be included in the IPCP. All patients will be followed for one month after discharge. IPCP consists of 8 informative contents such as preoperative preparations, surgical procedure, pain management, first mobilization, knee joint movements, exercise, discharge process, wound care, showering, nutrition, daily living activities, driving, sexual life, postoperative routine control, unexpected situations and etc. These informative contents will send to patients on days 7th, 4t and 1th days before the surgery and on days 1th, 2th, 3th, 5th an 7th days after surgery via whatsapp. Additionally, all participants will follow postoperative one month. |
| Standart of care | No intervention | –Patients in the control group will receive routine perioperative care and will follow postoperative for one month. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Elective primary unilateral knee arthroplasty planned,
- Having a smartphone,
- Literate,
- Have no communication problems and
- Agreed to participate in the study were included.
Key exclusion criteria (4 listed)
- Those with revision total knee arthroplasty
- Those with bilateral total knee arthroplasty
- Those with speech and hearing disabilities and cognitive problems such as Alzheimer's and dementia
- Patients who do not agree to participate in the study will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| increased perioperative communication programThanks to this communication program, informative content (8 times) will be shared with patients. | Other | Increased perioperative communication program |
Primary outcome
Postoperative complications
Time frame: 30 days
The investigators expect the IPCP to reduce early postoperative complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Results publication: PubMed 19427164Yoon RS, Nellans KW, Geller JA, Kim AD, Jacobs MR, Macaulay W. Patient education before hip or knee arthroplasty lowers length of stay. J Arthroplasty. 2010 Jun;25(4):547-51. doi: 10.1016/j.arth.2009.03.012. Epub 2009 May 8.
- Results publication: PubMed 29017803Day MA, Anthony CA, Bedard NA, Glass NA, Clark CR, Callaghan JJ, Noiseux NO. Increasing Perioperative Communication With Automated Mobile Phone Messaging in Total Joint Arthroplasty. J Arthroplasty. 2018 Jan;33(1):19-24. doi: 10.1016/j.arth.2017.08.046. Epub 2017 Sep 19.
- Results publication: PubMed 36716898Karimi AH, Shah AK, Hecht CJ 2nd, Burkhart RJ, Acuna AJ, Kamath AF. Readability of Online Patient Education Materials for Total Joint Arthroplasty: A Systematic Review. J Arthroplasty. 2023 Jul;38(7):1392-1399. doi: 10.1016/j.arth.2023.01.032. Epub 2023 Jan 27.
- Results publication: PubMed 7728691Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.
- Results publication: PubMed 21691907Clarke HD, Timm VL, Goldberg BR, Hattrup SJ. Preoperative patient education reduces in-hospital falls after total knee arthroplasty. Clin Orthop Relat Res. 2012 Jan;470(1):244-9. doi: 10.1007/s11999-011-1951-6.
- Individual participant dataSharing planned: Yes. The investigators will talk about sharing data with other researchers. But it can be useful.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cigdem Canbolat Seyman, PHD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing increased perioperative communication program in people with Knee Arthroplasty and Postoperative Complications, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06130813, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.